Joseph comes with a varied experience in Pharmacovigilance & IT. He is a Subject matter Expert on Safety Databases and on writing White Papers, his recently published white paper was on Role of technology in Vaccine Safety. He is currently the Head of Pharmacovigilance operations at Think-i.

His Key responsibility areas includes Developing module on pharmacovigilance, Delivering end to end pharmacovigilance training and participating in business development activities and medical writing services.

Prior to his role in Think I, he was supporting Pharmacovigilance activities for Baxter Inc. by doing Intake of cases for APAC team which included reports from Taiwan, Korea, Vietnam, Hong Kong, Indonesia and India and regulatory submissions for Korea via KAERS (Korea Adverse Event Reporting System) by working closely with Local Pharmacovigilance officers of each country.

Dr. Subodh Bhardwaj
Vice President Scientific & Medical Affairs

Dr. Bhardwaj is an innovative Medical Doctor with Post Graduation in Pharmacology and more than 30+ years of experience in Clinical Medicine, Clinical Research, Pharmaco-vigilance and Regulatory affairs.

He has planned and completed over 100 clinical trials ranging from Pre-clinical, Phase1-4 and pharmaco-epidemiological studies. Possess exemplary skills in Regulatory affairs in India and fully updated on EU, US regulations.

He has worked in Pharmaco-vigilance domain in over 30 years with some interesting publications. He has excellent Medical writing skills and Editorial experience with Indian Journal of Pharmacology with over 60 publications in National &International Journals

Dr. Salvi is a MBA from Indian Institute of Management, Kolkata, Doctorate in Applied biology, trained Six Sigma Black Belt with over 15 years of experience across the global and local Pharmaceutical/CRO, Tier I Medical Devices and BPO industry.

She has an experience in wide range of Therapeutic Areas, and had worked at all stages of Clinical Development from Phase II to production of clinical documentation necessary for product license applications.

Her areas of expertise include Clinical Trial operations, Risk Based Monitoring, Medical Writing and data publication, pahrmacovigilance, and feasibilities of new drug development and Analytics.

She is an industry expert, has been involved in key global industry forums such as the DIA, SCDM, CII and CPHI.

Mr. V. Dalal
Team Leader

Mr. Dalal is a certified Pharmacovigilance and Medical Writing professional, possessing more than 8 years’ of experience in authoring, review, team handling and project management of Pharmacovigilance aggregate reports, and review of scientific documents for regulatory affairs.

Mr. Kumar 7+ years of experience in pharmacovigilance operations. With managing team of drug safety staff to working with Medical Advisors/Medical Directors in preparation of project resourcing, Mr. Kumar is a Safety Processing Expert (SPE).

Mr. Kumar has also participated in face to face MHRA inspection for ongoing project at PAREXEL International.

Apart from his experience in Pharmacovigilance, Mr. Kumar is also a Medical Writer, his job function enabled him assessing and analysing adverse drug reactions including paediatric analysis, for inclusion/update of the CCDS (sections 4.8 & 4.9)

Ms. M. Morusupalli
Safety Associate

Ms. Morusupalli, a Post graduate in Pharmaceutical sciences comes, with a good experience in case processing of individual case safety reports.

Ms. Morusupalli has varied experience in carrying out Pharmacovigilance activities like literature searches, Preparation of deviation memo, Database searches, Registry and Triage of incoming cases to determine seriousness for prioritization of daily workflow, request translations as required (forward to LMD as appropriate) and Narrative writing for different trials.

Dr. Haq was also part of the safety team for carrying out Literature searches through EMBASE and PUBMED, shortlisting and summarizing of new and significant citations pertaining to investigational product. His function also included preparation of summary reports through secondary research.

Mr. C. Kulkarni
Manager Pharmacovigilance

Mr. Kulkarni is a result oriented professional with rigorous experience of over 9 years in the areas of Pharmacovigilance, Medical Information and Medical writing. He is presently spearheading as a Manager Pharmacovigilance in managing day-to-day PV activities.

Mr. Kulkarni has also served as the EU-QPPV Assistant for Hormosan Pharma GmbH

Mr. S. Jindal
Senior Drug Safety Specialist

Mr. Jindal Meticulous and highly accomplished professional with extensive experience in Drug safety.

Mr. Jindal is currently the Global Trainer for training of literature process to worldwide Affiliates of the client and is acting as an Affiliate for local literature search. His core competency is in case processing of individual case safety reports including determining the expectedness of adverse events against labelling documents, writing case narratives and assessing causalities.

Dr. Mahajan is seasoned Drug Safety professional with a varied and progressive 7 years of academic training and 3 year of professional hands on experience in Pharmacovigilance and drug safety case reporting (ICSR).

Mr. Court has core experience in pharmacovigilance with working knowledge of all the regulatory classes from drugs till cosmetics. Mr. Court has experience in handling oncology projects undergoing clinical phases and responsible for all the pharmacovigilance activities for the projects. He was also the SPOC for medical monitoring team and data management team for pharmacovigilance activities for both the projects.

Mr. Court was also a part of the aggregate reporting team and has extensive experience in preparation of regulatory reports such as DSUR’s, PSUR’s, PADERS and PBRER. He also performed quality checks of Safety data exchange agreements by coordinating with the vendors for transmission of safety data.

Mr. H.K. Nyathani
Safety Processing Expert

Mr. Nyathani is a dynamic seasoned professional with 8+ years of experience in drug safety. From having sound knowledge on product license configuration to integrate trade name and generic names to knowledge on SQL and PL/SQL in maintaining and tracking the Argus database Mr Nyathani is a problem solver and is of the capacity to develop solutions for the given tasks for supporting Safety database.

Mr. Nyathani is a study configuration Expert. He was a SPOC for the preparation of study guidance document (SGD) and Non interventional study (NIS) configurations in Argus console. He also has an experience as a review project Lead in providing trainings, assigning work to Vendors, tracking for timely completion and updating the status.

Mr. D.B. Bairagi
Senior Global Safety and PV Associate

Mr. Bairagi is an experienced Pharmacovigilance (PV) professional with over 6+ years of experience. He has varied experience in Pharmacovigilance and clinical operations. He was involved in the review serious adverse experience (SAE) reports received from Investigator sites and adverse experiences (AEs) from post marketing sources.

Mr. Bairagi was also part of the Quality review team and was engaged in Performing quality control checks of completed individual safety reports to ensure compliance with regulatory reporting requirements

Ms. P. Gupta
Manager Pharmacovigilance

Ms. Gupta is a seasoned subject matter expert on Pharmacovigilance with 9+ years of experience, she is currently Managing Pharmacovigilance operations for India.

She was Project Lead for clinical trial projects- set-up, project management, client liaison and represented Global Safety and Pharmacovigilance group at project team, client and Investigator meetings.

Ms. Gupta is also an excellent medical writer with her core competence in aggregate report writing DSUR, PSUR. PADER and has also Prepared and reviewed documents describing the process for monitoring and reporting serious adverse experiences e.g. SOPs, operating guides, Work instructions.

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Google Reviews

Anushree Jaiswal

I had completed M.pharm in cology in 2013 and after that i did 3 years Job then after the inspiration by Mr. Kamal the director of Cliniminds he told me about the impact of Vigilance and clinical research in current industry and influenced me to join the Course of Pharmacovigilance and clinical research.
...more
I had completed M.pharm in cology in 2013 and after that i did 3 years Job then after the inspiration by Mr. Kamal the director of Cliniminds he told me about the impact of Vigilance and clinical research in current industry and influenced me to join the Course of Pharmacovigilance and clinical research. This organization not only have great knowledge of Professor like Dr. Veepra and Mr. Joseph but great infrastructure and new techniques of learning like training in Safety ease as well as writing White paper etc, many more. Joining here is my turning point in life to get more confidence in these course. The Professors and Placement department is very friendly and trained to get a good job with good salary package.

Zeba ahmed
I am a BDS professional.I joined cliniminds to accomplish advanced post graduate diploma in pharmacovigilance with software training.Quality teaching is what defines this course the best.From the management itself to the study material to the online classes-everything was taken care of
...more
I am a BDS professional.I joined cliniminds to accomplish advanced post graduate diploma in pharmacovigilance with software training.Quality teaching is what defines this course the best.From the management itself to the study material to the online classes-everything was taken care of.My Facilitator -Dr Joseph is the biggest reason behind my accomplishment and has been the biggest source of inspiration.Recently i bagged an offer from Cognizant as a junior trainee data analyst-which would not have been possible without the effort of whole team of Cliniminds.Special Thanks to Dr Joseph for his continuous efforts and teaching me skills and thanks to Cliniminds for providing me with such a teacher.